Generics: Pioneered by Women

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As part of Women’s History Month, Chip Davis, president and CEO of the Association for Accessible Medicines highlights some of the most outstanding women that have worked in the generic pharmaceutical industry throughout history and pinpoints the women shaping today’s landscape for affordable and accessible medicines.

 

As we wrap up Women’s History Month, I would like to reflect on some of the trailblazers in the generic pharmaceutical industry

For centuries, women have led the way in health care and medical science, pioneering discoveries and treatments that have made our lives longer and more fulfilling. Throughout history, and even in the present day, these innovators have overcome discrimination on their way to major breakthroughs. As we wrap up Women’s History Month, I would like to reflect on some of the trailblazers in the generic pharmaceutical industry.

 

The most influential of these women was Agnes Varis (1930-2011), who liked to say that she deliberately avoided learning to type so as never to “drown in a typing pool.” The youngest of eight children of impoverished Greek immigrants, she grew up in Bay Ridge, Brooklyn and attended Brooklyn College. After working as a chemist for an industrial cleaning company, she moved into pharmaceuticals with the launch of three companies—Agvar, Marsam and Aegis. Her greatest contribution to the rise of generics came with championship of 1984’s Hatch-Waxman Act and 2003’s Medicare Modernization Act, which accelerated the path of generics to market.

 

Here are some (by no means all) other women who have made the generic pharmaceutical industry what it is today.

 

  • Carol A. Ammon began her career in 1973 as an associate scientist at DuPont. Twenty years later, she became president of the company’s generic pharmaceutical business unit, and in 1997 she led a management buyout team and purchased dozens of pharmaceutical products from the DuPont to form Endo Pharmaceuticals Inc. She led the company until her retirement in 2005. She then embarked on a second career as a nurse in order to go on humanitarian missions.
  • Jane Axelrad served as Associate Director for Policy at the FDA’s Center for Drug Evaluation and Research for 25 years until her retirement in 2016. She was instrumental in negotiating and implementing several key pieces of legislation, including the FDA Modernization Act of 1997 and the FDA Amendments Act of 2007. She was also one of the drivers of FDA’s 1992 Generic Monograph program. In the wake of the 2012 fungal meningitis outbreak, she headed negotiations to enact compounding provisions in the 2013 Drug Quality and Security Act and led the FDA’s efforts to adopt the legislation.
  • Elizabeth Dickinson has had a distinguished career at the FDA, serving as Chief Counsel from 2011 to 2017. Previously, she was legal counsel to the Center for Drug Evaluation and Research and the Office of the Commissioner on innovator and generic drug review issues, orphan drug development and biosimilars.
  • Diane Dorman served as the Director of Communications for the Generic Pharmaceutical Industry Association (which later became AAM). She then served as Vice President for Public Policy at the National Organization for Rare Diseases, securing improvements to the US Orphan Drug Program.
  • Jane Hirsh founded Copley Pharmaceutical in 1974, a highly successful generic drug company in the early years of the industry that was eventually purchased by Teva. In 1993, she became one of only three women running the thousand biggest corporations in America. She told The Chicago Tribune: “You have to believe you know what you know and stay focused on what you’re trying to achieve. There are always going to be naysayers, but it doesn’t matter whether you’re a man or a woman, it’s whether you’re good at what you do.”
  • Jean Hoffman started Newport Strategies in the 1980s, a generic industry data analysis company that practically all generic companies used in the early days. She also founded Q Street Advisors, a merger and acquisition consulting firm for the global generic industry, and then launched Safeguard, a leader in generic medicines for pets. Asked about her approach to leadership in 2012, she responded: “Hard work, listening, and being able to distill information and make sense of it. I’ve been able to see patterns and things other people didn’t see, in part because they weren’t listening as hard as I was.”
  • Jane Hsiao received her PhD in medicinal chemistry 1973 from the University of Illinois at Chicago after studying in Taiwan. In the 1990s she founded Ivax, which developed numerous respiratory, CNS, and oncology medicines before being purchased by Teva. Today she runs a number of humanitarian efforts through her family foundation.
  • Alice Till earned her PhD in pharmaceutical chemistry in 1979. After working at Merck for many years, she became vice president and then president of the Generic Pharmaceutical Industry Association—the organization that eventually became the one that I lead. In 2012, at 70 years old, she competed in a triathlon and raised hundreds of thousands of dollars for the Leukemia Lymphoma Society.

 

Today’s women leaders are scaling new heights and opening doors for a new generation of entrepreneurs and executives. They shared their experiences and insight last month in New Orleans at AAM’s annual Access! event. Nancy Snyderman, formerly NBC chief medical officer, moderated a powerful panel of leaders: Carol Lynch, president of Sandoz US and head of North America; Frances Zipp, president & CEO of Lachman Consulting Services; Silvia Perez, president and general manager of 3M Drug Delivery Systems; and Dr Rebekah Gee, secretary of the Louisiana Department of Health.

 

“As women,” said Lynch, “We’re more likely to engage in a conversation about the good we do for patients and the impact we make each and every day. Generally, we’re seen as caretakers, responsible for family health.”

 

Sharing examples of the discrimination she has faced in her career, Gee—a mother of five—stated, “It’s important to set an example, to pave the way, particularly in places when there aren’t a lot of females.” She recalled a moment when a male colleague marveled at her ability to simultaneously handle a phone call from home and an urgent policy matter. “It’s called multitasking,” she told him. “The second X chromosome was built for that!”

 

As president and CEO of AAM, I have partnered extensively with Heather Bresch, the visionary CEO of Mylan. I also have the privilege of collaborating with a number of influential women who serve on our board of directors, including Vanessa Brill (vice president and regional general counsel, the Americas, for Dr Reddy’s Laboratories), Lisa Graver (president at Alvogen America), Carol Lynch (president of Sandoz US and head of Sandoz North America), Marcie McClintic Coates (Mylan’s head of global policy – read her blog on a colleague whose sister died of breast cancer), Silvia Perez (president and general manager of the Drug Delivery Systems division of 3M), and Barbara Purcell (Bausch Health’s president, Diversified Products).

 

AAM has many women in leadership positions as well and recently launched Women in Health Policy, a network designed to increase the number of women guiding US healthcare and to amplify their professional advancement. Christine Simmon, our SVP of Policy and Strategic Alliances, and executive director of our Biosimilars Council, leads this important effort.

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